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We’ve bashed the horrible decision in Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010), more times than we care to count.  This time we’re taking a look precedent contrary to Bausch’s statement that “[t]here are no special pleading requirements for product liability claims.”  Id. at 558.  While that is true as a platitude, the fact of the matter is that TwIqbal does not recognize legal conclusions such as “X violated the FDCA” unless they are supported by facts that plausibly establish the purported violation.  Plaintiffs “cannot simply incant the magic words [defendant] violated FDA regulations in order to avoid preemption.”  Caplinger v. Medtronic, Inc., 921 F. Supp.2d 1206, 1224 (W.D. Okla. 2013), aff’d, 784 F.3d 1335 (10th Cir. 2015)

Thus, in the specific context of allegations of “parallel” claims that seek to evade preemption, most courts have recognized that “[p]arallel claims must be specifically stated in the initial pleadings.”  Wolicki-Gables v. Arrow International, Inc., 634 F.3d 1296, 1301 (11th Cir. 2011).

Continue Reading Preemption, Plausibility, and Parallel Claims
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As our loyal readers take a break from Halloween costume planning and other fall festivities, don’t forget to add registration for ACI’s Drug and Medical Device Litigation Conference, taking place December 3–4, to your to-do list.

As we mentioned, the good people at ACI have once again invited the blog to serve as a media sponsor, and they’re offering our readers a special discount. Use code D10-999-DDLB26 when you register to save 10% on your conference fee.

Several of our bloggers will be in attendance, and we’re looking forward to insightful presentations from the consistently outstanding faculty of in-house counsel, top defense firms, and seasoned jurists.

You can register here. We hope to see you in New York!

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We have always been flummoxed by California’s Sherman Law.  That is the California statute that purports to incorporate by reference the Food, Drug, and Cosmetic Act, supposedly making violations of that federal also offensive to state law.  Why does this matter?  Because there is no private right of under the FDCA, and 21 U.S.C. § 337 expressly reserves the right to enforce the FDCA to the United States, not private parties.  Despite this, some courts have allowed private parties to evade section 337 by permitting private actions under California’s Sherman Law, even though the allegations amount to violations of the FDCA.  It’s a federal wolf in California sheep’s clothing. 

The Ninth Circuit recently took on this conundrum in an unpublished opinion and held that the FDCA means what it says—there is no private right of action, even if the plaintiff has shrouded its claims in the Sherman Act’s rubric.  In Bubak v. Golo, LLC, No. 24-492, 2025 WL 2860044 (9th Cir. Oct. 9, 2025), the plaintiff brought a claim under California’s Unfair Competition Law (or “UCL”), which permits lawsuits by private parties who have suffered injuries because of any “unlawful, unfair, or fraudulent business act or practice.”  Id. at *1.  The claim was premised on an alleged violation of the FDCA “as incorporated into California law in the Sherman Food, Drug, and Cosmetic Law,” which is a typical use of the Sherman Law as an end run. 

The district court dismissed the complaint, and the Ninth Circuit affirmed in an unpublished opinion, with a concurring opinion that confronts the issues head on.  Citing its precedential opinion in Nexus Pharmaceuticals, Inc. v. Central Admixture Pharmacy Services, Inc., 48 F.4th 1040 (9th Cir. 2022) (discussed here), the Ninth Circuit held that the plaintiff’s claims were prohibited by federal law:

The FDCA expressly prohibits private enforcement.  In Nexus, the plaintiff sought to avoid this prohibition by bringing claims under the UCL and other state laws that “incorporate” the FDCA.  We explained, however, that these claims are preempted because they “rest upon a violation of the FDCA,” and proceedings to enforce or restrain violations of the FDCA “must be by and in the name of the United States, not a private party.”

Bubak’s claims face the same problem.

Bubak, at *1 (citing section 337, quoting Nexus Pharma).  Because the plaintiff’s claims required litigating violations of the FDCA, the plain language of the statute prohibited them.  Moreover, the plaintiff’s attempts to distinguish Nexus fell flat—both cases involved the Sherman Law; Nexus was not limited to pharmaceuticals; and both brought claims that existed “only by virtue of the FDCA.”  Id. at *1-*2.  The plaintiff’s reliance on a more recent Ninth Circuit opinion going the other way, Davidson v. Sprout Foods, Inc., 106 F.4th 842 (9th Cir. 2024), was misplaced.  In Davidson, the Ninth Circuit allow state-law claims based on violations of the FDCA because the alleged violation was “plain,” whereas the alleged violations in Nexus and Bubak “required litigating.”  Id. at *2.  (You can read our take on Davidson case here.) 

The court therefore affirmed the dismissal, but the concurring opinion offers the greater insight, particularly in urging that the court overrule Davidson.  The Davidson opinion cannot be reconciled with the earlier Nexus opinion, and the idea that the plaintiffs in either case alleged claims under California’s Sherman Law, and not the FDCA, is pure fiction.  The FDCA’s bar on private enforcement does not carve out an exception for “plain violations,” and there is no principled basis for concluding that the FDCA reserved enforcement of some violations to the federal government, but not others.  Bubak, at *3. 

The concurring opinion saw only one way to reconcile Davidson with earlier precedent.  In Davidson, the plaintiffs’ claims predated enacted of the relevant provisions of Sherman Law and “thus exist[ed] independently of” federal law.  Id.  In the view of the concurring judge, the FDCA’s bar on private enforcement would not reach such claims, since they would not be predicated on violations of the FDCA. 

We see the concurring opinion’s point, but this judge might be slicing the onion a bit too thin.  If a plaintiff brought a UCL claim invoking some violation of the Sherman Law that was truly outside the FDCA, that claim theoretically could proceed.  But would have to see a concrete example to believe it.

The more useful takeaway from Bubak is that California’s Sherman Law is not a highway around the FDCA’s ban on private enforcement.  The opinion correctly treats Nexus as prohibiting state law claims alleging violations of the FDCA, and its attempt to cabin Davidson is equally useful, since most every claim under the FDCA will “require litigating” and thus will be preempted.  Not that we would object to an opinion expressly overruling the wrongly decided Davidson opinion.  That would be good, too.    

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As defense lawyers, we have dealt many a time with plaintiffs’ attorneys who get away with just about everything. Failing to appear for hearings. Failing to oppose motions. Ignoring court orders. Ignoring discovery requests.

When unjustified, such acts of neglect should not be excused, but they often are. Courts are predisposed to decide cases on the merits, and loathe to force plaintiffs to bear the consequences of the actions (or inactions) of poorly-chosen legal counsel. Thus, more frequently than you might expect, courts will overlook blown deadlines and court-imposed requirements for those on the other side of the “v.”

Rule 60(b) of the Federal Rules of Civil Procedure provides guidance for discerning between errors that are justifiable and those that are not, but we’ve always found it a bit cryptic:

On motion and just terms, the court may relieve a party or its legal representative from a final judgment, order, or proceeding for the following reasons:
(1) mistake, inadvertence, surprise, or excusable neglect

You do not wind up in Rule 60 motion territory without some kind of mistake or neglect, or inadvertence or surprise. The ultimate question is whether the goof-up is one that can be justified or excused, and that is where we think Rule 60 could do with a little more detail.
Our griping aside, some attorney errors are obvious even under the vague Rule 60(b)(1) test. Which brings us to Donate v. Smith & Nephew, Inc., 2025 U.S. Dist. LEXIS 197226, 2025 WL 2829196 (Oct. 6, 2025 E.D. La.).

Donate came to our attention because it is a medical device (knee replacement) product liability action. After the defendant removed the case to federal court, the plaintiff’s lawyer registered with the federal court ECF system.

And that apparently was about the last thing he did, until five months after the court entered judgment against the plaintiff for failing to oppose a motion to dismiss and failing to respond to an order to show cause about said failure to oppose the motion to dismiss.

Once plaintiff’s counsel finally came to, he moved for relief from judgment under Rule 60(a)(1), arguing excusable neglect in that his email address had changed, he failed to update it in the ECF system, and thus he had not received any filings or orders after the removal.

The court—the venerable Judge Eldon Fallon, not one who is quick to penalize plaintiffs for their attorneys’ minor mistakes—rejected plaintiff’s arguments, emphasizing that local rules require attorneys to maintain current contact information in the electronic filing system. Indeed, the rules also require attorneys to diligently monitor the status of their cases, and plaintiff’s counsel did not check the docket or contact the court’s clerk either.

Relying on the Fifth Circuit’s gloss on Rule 60(b)(1) from Trevino v. City of Fort Worth, 944 F.3d 567 (5th Cir. 2019), Judge Fallon agreed that this conduct amounted to gross carelessness, and counsel’s ignorance of his obligations under court rules did not justify relief under Rule 60(b)(1) either.

The court also addressed the appropriateness of dismissal with prejudice, noting that lesser sanctions would have been futile under the circumstances. It had attempted to reengage plaintiff’s counsel through the show cause order, but counsel’s failure to update his contact information rendered such efforts ineffective.

It seems like it should not be necessary to say this, but apparently it is: Lawyers need to keep their addresses updated with the court, and keep an eye on their cases, particularly if things have unexpectedly gone silent.

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There is a documentary out on the actor Charlie Sheen and it reminded us that, long before the current denizen of the White House crowed about “winning,” that was a staple of many bizarre rants by Sheen. 

We’re not ranting, whether bizarrely or sanely, but it is nice to post about yet another defense win in Filshie clip litigation.  The case is Banet v. Cooper Co., 2025 U.S. Dist. LEXIS. 193141 (W.D. Kentucky Sept. 30, 2025).  The plaintiff made the usual claim – that the Filshie Clip tubal ligation device migrated and caused an injury.  The particular injury in Banet seemed serious. The clip could not be removed safely.  

The plaintiff filed a complaint with three counts: strict liability design and marketing defect; (2) negligence; and (3) punitive damages.  Of course, punitive damages is a form of relief, not a separate cause of action. The court pointed that out and – spoiler alert – the count was going nowhere.  Why do plaintiff lawyers keep making this mistake? Anyway, the key issues in the Banet case were personal jurisdiction and federal preemption. 

Personal Jurisdiction

A couple of entities escaped on personal jurisdiction grounds, because they were merely corporate affiliates that did not actually do anything in Kentucky and did not constitute alter egos of the main defendant.  One entity (CSI) did not escape on jurisdictional grounds, and the court’s reasoning is a bit fishy.  The court applied a version of Kentucky’s long-arm statute that has since been repealed and replaced, so maybe the ruling is no big deal.  Still … while CSI had ceased being a distributor before the date of the plaintiff’s surgery, the court kept it in the case based on a “possible inference” that “by establishing a pre-existing sales arrangement with Twin Lakes, CSI caused Banet to be implanted with defective Filshie Clips. To wit, had CSI not regularly marketed and/or sold Filshie Clips to Twin Lakes, Utah would not have continued to provide Filshie Clips to the hospital and Banet’s medical provider would have used another contraception device.” That sounds less like reasoning than speculation.  Indeed, it sounds like a judicial exercise in counterfactuality with all the plausibility of the glorious Hot Tub Time Machine movie franchise. But whatever, the case gets dismissed anyway, and now we’ll get to the good part. 

Federal Preemption

The Filshie Clip is a class III medical device that received premarket approval (PMA) by the Food and Drug Administration (FDA), meaning that broad express preemption applies, barring claims for both design defect (a different design would require a new FDA approval) and inadequate warning (the proposed new warning would vary or add to the device’s FDA-approved warnings). 

The plaintiff argued that she “sufficiently pleaded that the Defendants violated the requirements of the Filshie Clips’ PMA,” but the court pointed out that “nowhere in the paragraphs she cited in support of this contention (nor anywhere else in the Complaint) does she allege that the design for the Filshie Clip used in her surgery different from the design approved by the FDA.” Accordingly, adios to the design defect claim. 

As is usual in Filshie Clip cases, the plaintiffs ultimately asserted a claim for failure to report adverse events to the FDA. (The “marketing defect” claim originally offered nine different theories, including, inter alia, “failing to disclose that the Filshie Clip was inadequately tested,” and failing to convey post-marketing warnings, but the plaintiff abandoned those theories and pushed all her chips in on the alleged failure to report adverse events. That claim was also preempted because it presupposed the insufficiency of the device’s FDA-approved warnings.   

Any duty to warn physicians, whether directly or indirectly through the MAUDE database, is different from, or in addition to, the FDA-approved warnings.  “Any claim that Defendants were required to provide additional ‘warnings’ via MAUDE necessarily presupposes that the FDA-approved warnings contained within the Filshie Clips labeling and marketing were themselves insufficient to ‘adequately guard against the inherent danger.’” Allowing a jury “to determine whether Defendants’ FDA-approved warnings were inadequate based on ‘any non-disclosed information is the kind of inter-branch meddling that concerned the court in Buckman … and would both usurp the agency’s role and go beyond the court’s institutional expertise.’” Just so. 

Lately, in all sorts of litigation, this structural, separation of powers point seems to be packing a powerful punch. The intemperate and inaccurate political yammerings about abuse of judicial authority are regrettable, but it is possible that at least some courts have shown an increased sensitivity to accusations of judicial overreach. Incursions on executive branch authority are to be studiously avoided. Incursions on Congressional authority … well, actually, what is that, anyway, these days?

The negligence claims in Banet failed for the same reasons as the strict liability claim failed. Again, the squishy litany of allegations boiled down to failure to report adverse events and, again, preemption ruled the day. Moreover,  a “laundry list” of negligence allegations was not specific enough to state a claim. The court dismissed the claims. Even without “tiger blood,” winning by the defense is always welcome news in this blog. 

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We call a treating physician who testifies to more than just their treatment a hybrid expert. But doctors who both treat and testify can sometimes be less “Doctor Do No Harm” and more “Doctor Show Me the Money.” And when their treatment comes under a letter of protection (“LOP”), things get even murkier. Like, swampy Florida-murky. Which is oddly fitting since today we are talking about Dyer v. Coloplast Corp., 2025 U.S. Dist. LEXIS 200241 (M.D. Fla. Oct. 9, 2025).

Before we get into the case specifics, this is not an attack on treating physicians. Most are competent, ethical professionals who want to help people. But when a doctor is treating under an LOP and then testifying in court with the flair of a paid actor in a late-night infomercial, defendants have to ask–is this about the patient, or the payout?

Plaintiff in Dyer sued the manufacturer of the pelvic sling that was surgically implanted to treat her stress urinary incontinence and pelvic organ prolapse. The sling later was removed due to side effects. Defendant served discovery requests on both plaintiff and her explanting surgeon seeking production of documents related to plaintiff’s counsel’s relationship to the explanting surgeon, including any LOPs, billing agreements, or other documents reflecting referrals and financial relationships.  Plaintiff and her doctor moved to quash and defendant moved to compel.  The opinion starts by dealing with technical and procedural issues. Like that both plaintiff and the physician filed motions to quash in the wrong court–not the court where compliance would occur—and that they filed too late. Id. at *7-9. Or that personal service of Rule 45 subpoenas was not required; giving the subpoena to an employee at the address listed for the physician in plaintiff’s disclosures was reasonably calculated (and did) ensure receipt. Id. at *11-12.

The court also rejected the surgeon’s arguments that the requests sought protected health information (“PHI”) that patient-physician privilege prohibited him from disclosing. Not only did the requests for financial relationship documents not call for PHI, the defendant agreed that if responsive documents did contain such information, it could be redacted. Id. at *13.

So that left only whether discovery of LOPs or financial relationships should be permitted at all. For those blissfully unaware, an LOP is an agreement between a plaintiff’s attorney and a medical provider.  The medical provider agrees to treat the plaintiff now, and in return, the attorney promises to pay the treater later, out of any settlement or award the plaintiff may receive. It’s like a medical IOU. While there may be instances where an LOP is used because a plaintiff cannot otherwise get medical treatment (uninsured), it can also be a litigation strategy. Plaintiff’s counsel refer their clients to physicians who are experienced courtroom testifiers. Now you have a doctor testifying in court who has a quiet financial interest in the outcome, or maybe a not-so-quiet one.

Hybrid expert witnesses are unique creatures. They testify as treating doctors (so they’re supposedly neutral), but they also function like retained experts. That’s not inherently bad. But there is no dispute that discovery of how much retained experts are getting paid to testify is warranted. Everyone agrees it can go to bias. So, the same rule should apply to treating doctors. Defendants should be able to know and cross-examine treaters on their financial interest in the litigation and their financial relationship to plaintiff’s counsel.

Afterall, if a doctor has treated dozens of patients referred by the same law firm, all under LOPs, and all leading to litigation… well, we’re not in Hippocratic territory anymore. We’re in transactional medicine, dressed up as medical opinion. Without discovery, the defense is left poking around in the dark, while the jury sees a white coat and assumes objectivity.

Which brings us back to Dyer and Fla. Stat. §768.0427(3), enacted in March 2023. The statute requires disclosure of any LOP (broadly defined), as well providing generally that the nature of the financial relationship between a law firm and a medical provider is relevant to the issue of bias—making it discoverable. Plaintiff in Dyer, however, tried to rely on pre-2023 cases to quash the discovery. Such as Worley v. Central Florida YMCA, Inc., 228 So. 3d 18 (Fla. 2017), in which the court held that “a lawyer’s referral of a client to a treating physician was a confidential communication protected by the attorney-client privilege.” Dyer, at *15. Fortunately, §768.0427 overturns Worley; therefore, plaintiff and her surgeon were ordered to respond to the discovery. 

Hybrid experts are not the enemy—but unchecked financial bias is. Pulling back the curtain and allowing some of that Florida sun to shine on LOPs is doing the right thing. 

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The billion-dollar-plus verdict in United States ex rel. Penelow v. Janssen Products, LP, 2025 WL 937504 (D.N.J. March 28, 2025), epitomizes everything that is wrong about the False Claims Act – and that’s just about everything.  A private plaintiff (“relator”), purporting to act as a self-appointed agent of the United States government, claimed that the defendant engaged in “off-label promotion” of a drug in violation of the FDCA.  There is no indication that any patient was harmed or that the drug was ineffective for the off-label use at issue.

Yet the relator, claiming to wield unconstitutionally diverted federal enforcement power, was allowed to recover an identical amount for each of almost 160,000 supposedly “false” claims.  That the off-label prescriptions provided the recipients with “effective treatment for patients with HIV,” was simply ignored as “an alleged benefit [that] is intangible and impossible to calculate.”  Penelow, 2025 WL 937504, at *9.  But “the Government [not the patients] did not receive any tangible or measurable benefit,” so the relator was allowed to recover “the full amount” that the government paid for all of the nearly 160,000 claims.  Id.  If that is the law, then the law is an ass – effective treatment is precisely what government health programs are supposed to provide.

That already inflated “damages” number was then trebled, and on top of that a uniform penalty of $8000 each was imposed on every claim that “those physicians and Plan Sponsors ultimately made to healthcare programs.”  Id. at *15-16.  That led to an astronomical $1.2 billion award that, in itself, seems unconstitutional as an excessive fine.

We’ve already discussed in other posts the constitutional issues involving diversion of executive branch enforcement power to private FCA relators and the excessive nature of statutory penalties rotely multiplied over huge numbers of ostensibly separate claims.  This post discusses that part of the government’s brief “as intervenor and amicus in support of neither party” that concedes that the trial court made a mistake when it held that any submission of a claim involving an off-label use qualified as a “false” claim under the FCA.  The government admits that this aspect of the opinion misstated the law:

Most notably, the district court stated that relators had “introduced evidence that demonstrated [defendant’s] marketing of [the drugs at issue] were [off-label], and that this [off-label] marketing violated an express condition of payment for reimbursement under Medicare, Medicaid, or ADAP [AIDS Drug Assistance Program].”  “Taken together” with other evidence, the court determined, this evidence would have allowed “a reasonable jury” to find “that claims for [the drugs] submitted to Medicare, Medicaid, or ADAP were [off-label] and ineligible for reimbursement.”

DoJ br. at 36 (citations omitted).

We agree 100% with the government’s  smack-down of that language.  The Medicare statute makes it crystal clear that, for purposes of government programs, reimbursability exists either for a labeled drug indication or alternatively an off-label use listed as accepted in one of several medical compendia.  “The term ‘medically accepted indication’ means any use for a covered outpatient drug which is approved under the [FDCA] or the use of which is supported by one or more citations included or approved for inclusion in any of the compendia described in subsection (g)(1)(B)(i).”  42 U.S.C. §1396r-8(k)(6).  Want more authority?  Bexis has it compiled.  See James M. Beck, “Off-Label Use in The Twenty-First Century: Most Myths & Misconceptions Mitigated,” 54 UIC J. Marshall L. Rev. 1, 32-35 & nn. 151-63 (2021).  The law hasn’t changed since then.

This flat-out error similarly manifested itself in the jury instructions that led to the initial verdict (then trebled and assessed penalties).  As the DoJ brief puts it:

The district court also erred when it instructed the jury that federal healthcare programs “will cover and pay for a drug that is used for a ‘medically accepted indication,’ which means any FDA-approved use on the label that is supported by one or more citations in certain drug compendia.”  An indication for the use of a drug is medically accepted if the drug is FDA-approved for that indication or if the use of that drug for that indication is supported by drug compendia. . . .  [H]ad [the district court] included the words “or one” after “FDA-approved use on the label,” its instruction would have been correct.  But the omission of those words suggested incorrectly that FDA approval of a drug for a particular indication is necessary for the drug to be medically accepted for that indication.

DoJ br. at 38-39 (citations omitted) (emphasis added).  This discussion further demonstrates why it’s a terrible idea to delegate executive enforcement authority to private parties with dollar signs in their eyes who don’t give a damn about federal law being misapplied if it helps them recover.

Of potentially greater long-term impact is the government’s nuanced view of the relationship between off-label promotion and the FCA.  “[T]he FDCA’s misbranding provisions govern how drugs may be marketed; they do not govern whether federal healthcare programs will reimburse for the drugs, as prescribed for particular patients.”  DoJ br. at 36.  The test is not off-label use, but whether the prescription itself is “reasonable and necessary.”  Id. Thus, the government will reimburse off-label use when it meets that standard, but it will not reimburse even on-label use that does not.

In other words, compliance with the FDCA is not a condition of Medicare reimbursement. . . .  The district court was therefore incorrect to the extent its post-trial opinion suggested that off-label marketing by [defendant], in and of itself, “violated an express condition of payment for reimbursement under Medicare, Medicaid, or ADAP,”  A finding that a company has marketed its drugs for off-label uses is not, without more, sufficient to find that subsequent claims for the marketed drugs are false within the meaning of the False Claims Act.

DoJ br. at 37.  Given that the same judicial error infected both the jury instruction and the court’s later opinion, the error plainly was not an accident, but rather reflected judicial misunderstanding of both Medicare standards and FCA liability.

But we think that there is more to it than that.  The standard that DoJ cites for reimbursement of off-label use – whether “use of that drug is . . . reasonable and necessary for the patient,” id.at 36 – is patient and physician specific.  Given an individualized standard for whether off-label use (promoted or otherwise) is reimbursable, then it is not possible to assess damages or statutory penalties in gross.  In Penelow there was no individualized assessment of either liability or damages.  All the nearly 160,000 supposed mass claims were analyzed in one fell swoop.  The discussion of whether “false” claims existed in Penelow totally ignored whether any prescription, on- or off-label, was “reasonable and necessary for the patient.”  While not a single prescribing physician testified, the district court ruled that the relators had provided evidence sufficient to prove liability anyway.

[Defendant] contends that . . . the record is insufficient to demonstrate causation because Relators did not present any “doctor-[specific] or patient-specific evidence to demonstrate the alleged off-label marketing effect on prescribing in any individual doctor’s office.”  [Defendant] raised this same argument at summary judgment and the Court squarely rejected [that] contention.

Here . . . the Court finds that Relators produced sufficient evidence from which the jury could reasonably adduce that [defendant’s] OL [off-label] marketing was a substantial factor in causing physicians to submit claims for reimbursement to Government payors.

2025 WL 937504, at *4 (citations omitted).

As the government now concedes, in “squarely rejecting” the defendant’s argument that some (probably the great majority) of the off-label use was considered proper medical care by the treating physicians, the trial court was just as squarely wrong.  The DoJ informed the Third Circuit:

  • FDCA violations do not make claims “false” under the FCA by themselves.  While the FDCA governs how drugs may be marketed; federal healthcare programs decide what’s reimbursable.  FDCA compliance is not a condition of payment.
  • FDA drug (or device) approval is not a prerequisite to reimbursement.  Medicare Part D covers drugs used for “medically accepted” indications, which include both FDA-approved uses and compendia-supported uses.  What matters is for the treatment to be reasonable and necessary for the individual patient.  42 U.S.C. §§1395w-102(e)(3)(A); 1395y(a)(1)(A).
  • Off-label can be reimbursable, and on-label can be non-reimbursable, depending on whether the particular use is reasonable and necessary for a particular patient.
  • What is “reasonable and necessary” is an individualized determination made in the first instance by the prescribing physician following accepted standards of medical practice and patient-specific medical circumstances of the individual case.

Thus, the jury’s verdict, and the in gross legal reasoning that allowed it, that some 160.000 claims were “false” with no individualized assessment whatever, is not how the government currently (or probably ever) understands the False Claims Act to operate.  The Medicare Benefit Policy Manual, for one, states:

Determinations as to whether medication is reasonable and necessary for an individual patient should be made on the same basis as all other such determinations (i.e., with the advice of medical consultants and with reference to accepted standards of medical practice and the medical circumstances of the individual case).

Policy Manual §50.4.3, at unnumbered p. 56.

Unfortunately, while it’s not the law, it’s a well-worn plaintiffs’ strategy in drug and device FCA cases to collapse the FDCA into the FCA and proclaim that alleged misbranding or off-label promotion automatically makes every resulting reimbursement claim “false.”  Reimbursements  are not “false” merely because they may have been influenced by off-label promotion.  They are “false” only if the government would not have paid for the treatment as “reasonable and necessary” medical treatment.  The DOJ’s Penelow brief is a clear, official governmental statement that FCA falsity in drug cases turns on the payor’s reimbursement standards, not the FDCA, and that “reasonable and necessary” is an individualized, patient-and-physician-driven determination.  FCA defendants will want to use it to demand claim-by-claim, patient-specific proof and to defeat efforts to convert marketing allegations into blanket FCA liability.

That’s the key takeaway we see from the DoJ brief in Penelow – that in gross calculations that led to the absurdly large award in that case are entirely improper in off-label use-related FCA litigation.  The mindless multiplication of damages and penalties that occurred in cases like Penelow represents an erroneous expansion of liability created by courts that let financially driven FCA private relators run wild with their ill-gotten government enforcement powers.

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To all in-house counsel working in the pharmaceutical, medical device, biotech, and digital health industries: if you’re looking to complete a few final CLE hours before the end of 2025, we invite you to attend Reed Smith’s annual Virtual Life Sciences CLE Week, taking place from November 3 through November 7, 2025.

This week-long event will feature a series of timely and thought-provoking sessions focused on the legal and regulatory issues shaping the life sciences industry today. Several of your favorite bloggers will be speaking. Topics will include developments in artificial intelligence, evolving drug pricing frameworks, key ethical considerations, fraud and abuse enforcement trends, vaccine product liability developments, emerging product liability and toxic tort issues, transactional insights, and legal perspectives on women’s health.

Here are descriptions of the topics and the registration link.

The New EU Product Liability Directive | Presented by Lisa M. Baird, Daniel Kadar, Jamie L. Lanphear, Cynthia O’Donoghue, Oliver Rathje, and Wim Vandenberghe | This session unpacks the sweeping changes in the EU’s new Product Liability Directive and how they impact risk for life sciences and digital health companies operating in the EU.

Life Sciences Early-Stage Dealmaking | Presented by Nicole J. Aiken-Shaban, Michelle A. Mantine, Sarah Thompson Schick | A practical overview of early-stage life sciences deals trends and the critical diligence, regulatory, and antitrust considerations companies must navigate.

Navigating the Evolving Frontier of Women’s Health and Fertility Treatments | Presented by Sarah Cummings Stewart and Kristin B. Parker| Explore the shifting legal and regulatory landscape affecting women’s health and fertility treatments, with actionable strategies for compliance and risk management.

From Pharma to Produce: California’s Evolving Tort Terrain | Presented by Steven J. Boranian and Sarah B. Johansen | This California-focused legal update covers key tort developments impacting industries from pharmaceuticals to food, with implications for future litigation strategies.

AI and Life Sciences: A Collision Course | Presented by Tyler J. Thompson and Abigail Walker | Dive into how emerging U.S. AI regulations uniquely affect life sciences companies and what compliance measures should be taken now to prepare.

Recent Developments in Vaccine Product Liability Litigation | Presented by Jim Beck | Gain insight into the legal framework and current litigation trends surrounding vaccine liability, including the Vaccine Act, PREP Act, and COVID-19-related cases.

A World Without Government Pricing Programs | Presented by Joesph Metro | This session explores the legal, operational, and ethical implications for drug manufacturers considering alternatives to participation in federal pricing programs.

AI and Ethics: Navigating and Challenging Improper Use in Legal Proceedings | Presented by Jaclyn M. Setili Wood, Christian W. Castile and Charlotte Flynn| Learn how courts are responding to AI misuse in litigation and how legal teams can proactively address ethical and evidentiary challenges.

Hot Topics in Fraud and Abuse for Medical Device Manufacturers | Presented by Caitlin Chambers and Nancy Bonifant Halstead | An in-depth look at recent enforcement trends and compliance strategies to address key fraud and abuse risks facing medical device manufacturers.

Toxic Tort Litigation in the Life Sciences and Consumer Health Industry: Key Cases and Emerging Trends | Presented by Matthew D. Jacobson and Alexis A. Rochlin | A forward-looking analysis of the evolving toxic tort landscape, featuring notable cases and risk mitigation strategies for life sciences and consumer health companies.

Something New Under the Sun? Novel Preemption Topics | Presented by Lisa M. Baird and Heather A. Ritch Rocks | Explore emerging preemption issues for biosimilars and de novo devices, with expert perspectives on how courts may shape the future of product liability defenses.

CLE Information


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We’ve been defending drug and device litigation for a long time, and we’ve seen many plaintiffs who experienced real injuries. Those of us at the blog, our colleagues at other defense firms, and our clients are genuinely sympathetic to injuries a plaintiff actually experienced. Many plaintiffs we’ve encountered also endured terrible circumstances earlier in their lives. Some of those can be heartbreaking. Defending cases on the basis that our clients’ products did not cause the injury or that the injury was a known and warned of risk doesn’t mean the defense bar looks askance at plaintiffs and their experiences.  But, when we see a case involving a syringe needle purportedly propelled into a plaintiff’s derrière, some of us might exhibit a moment of minor moral weakness and include the above title in a blog post. Mea culpa.

Today’s case, Rudzinskas v. Retractable Techs., Inc., 2025 U.S. Dist. LEXIS 191860 (S.D. Ga. Sept. 29, 2025), involves a type of syringe that automatically retracts once the plunger handle is fully depressed.  Plaintiff’s husband regularly administered vitamin B-12 shots to her and had been doing so for six or seven years. Plaintiff claimed that, on one of those occasions, the needle from defendant’s syringe “shot into [her] like a slingshot.” Id. at *4.  Plaintiff went to the hospital and an ultrasound suggested the needle was embedded in the plaintiff’s buttock. Plaintiff underwent surgery to have the needle removed, but the surgeon was not able to extract it. 

Continue Reading A Real Pain in the  . . .
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Not too long ago, we tried to extrapolate from a doctoral thesis on quantum dots to lessons for litigation.  That “[q]uantum dots are between one-billionth of a meter and one-hundred-millionth of a meter in size” emphasized that “appreciating the scope and scale of what is being discussed can be critical.”  In the spate of litigation over alleged contaminants and degradation products in a variety of over-the-counter and prescription drugs, it seems rare that the plaintiffs want to talk about scale beyond that a particular chemical can be detected at all.  Not us.  Trace chemicals in a sample are often discussed in terms of parts per million (“ppm”).  The amount of a chemical that is known to be harmful (e.g., carcinogenic) in a particular organism might be discussed in terms of grams of exposure per kilogram of body weight of the organism, sometimes with a frequency included.  The number of molecules in a mole of a substance is about 602,214,076,000,000,000,000,000.  The number of molecules in a gram of substance depends on the molecular weight of the substance, but it will typically be in the sextillion range.  For a little context, 1 ppm would be one person out of ten stadiums full of 100,000 people each.  If that person weighs 75 kg, then a risk threshold (or lowest observable effect level) of 1 gram per kilogram of body weight per day would require 75 grams per day.  If we are talking about 200 mg of an NSAID, then that person would need to take 375 of them per day.  If we are talking about a trace contaminant or degradation product that occurs at 2 ppm in that NSAID, then that person would need to take 187,500,000 of those NSAIDs per day to hit that threshold.  We could probably go on discussing the number of molecules, the molecular weight of benzene, or other math-adjacent stuff that would make Thomas Dolby proud.  We will not, but this exercise is actually relevant to a case based on a claim that the medical product at issue has a detectable trace amount of benzene or some other contaminant or degradation product in it.

This week, we have two separate purported class actions for consumer protection over different OTC drugs that were dismissed by two very different courts on preemption grounds.  Kouyate v. Harvard Drug Grp., LLC, No. 1:24-cv-6223-GHW, 2025 U.S. Dist. LEXIS 190152 (S.D.N.Y. Sept. 26, 2025), concerned an acne face wash that contained benzoyl peroxide.  Leonard v. CVS Pharmacy, Inc., No. 5:24-cv-06280-EJD (N.D. Cal. Sept. 29, 2025), concerned cold and flu medicines that contained guaifenesin.  Although we used the past tense above, each plaintiff was given the chance to replead non-preempted claims.  Each also based his/her claims on the purported presence of small but unspecified amounts of benzene in their respective products and the respective manufacturer’s failure to deviate from the FDA-required labeling to describe the purported benzene.  We think that these decisions are close enough to discuss together, adding to our many prior posts about similar claims, including with these same drugs.  See here, here, and here for a sampling.  Kouyate came out first and has a more extensive preemption discussion, so we will address it first.

The plaintiff in Kouyate bought his OTC acne wash knowing it had benzoyl peroxide and purportedly believing it did not have any benzene in it.  (The complaint actually alleged that plaintiff filled a prescription, but that seems like the same sloppiness the court noted from the lawyer re-using complaints.  2025 U.S. Dist. LEXIS 190152, *9 n.3.  This is an OTC product.) He alleged that benzoyl peroxide can degrade into benzene over time, and that an “independent laboratory” found his acne wash had “unsafe levels of benzene” in it.  Id. at *1.  Based on this, he brought a class action under New York law for false advertising, common law fraud, and negligence per se based a state criminal statute banning misbranded and adulterated drugs.  To us, these allegations scream preemption, both express preemption and under Buckman.  Yet, the court offered a careful analysis of the preemption issues, an analysis that we think would have supported not giving plaintiff a third shot to plead non-preempted claims.  We also think that the court’s conclusions that plaintiff had not pleaded the false advertising claim—which required an affirmative misrepresentation—or a common law fraud claim—which required the basic fraud elements pled with particularity—also supported not giving plaintiff another shot on those claims.  Id. at *47-56.  (Evaluating the adequacy of pleading first, as we usually advise, also might have helped.)  It also should have been pretty clear that any attempt at negligence per se, even though based on a violation of state law, would be preempted because it amounted to a stop selling claim.  We are getting a little bit ahead of ourselves, though.

The product at issue in Kouyate was governed by a monograph that set out specific requirements for the labeling of a benzoyl peroxide containing acne wash, including the percentage of benzoyl peroxide, a list of inactive ingredients, specific warnings, and directions.  The monograph does not require or otherwise address any disclosure of the possibility that some small amount of benzene might be created by the degradation of the benzoyl peroxide.  The labeling for defendants’ products uncontestably complied with the monograph requirements and did not include any affirmative misrepresentations (e.g., “This has no benzene,” “None of the ingredients will ever degrade into another chemical substance at all.”).  Keeping in mind that the plaintiff did not assert any product liability claims that would have been exempted from the express preemption provision for OTC drugs, the simple conclusion was that any change in labeling plaintiff claimed was required to avoid violating the state false advertising statute and/or common law fraud requirements was going to be “different from or in addition to [or] otherwise not identical with” the FDCA requirements imposed through the monograph.  Id. at *24-26.  Relying heavily on the Second Circuit’s decision in Critcher, which evaluated the express preemption provision for cosmetics in the context of a case about the labeling of the amount of skin cream in a container, the court rejected the argument that the FDA requirements were insufficiently specific to preempt plaintiff’s claims about additional labeling language.  Id. at *27-31.  Indeed, benzene, whether present at 2 ppm or more, is not “an active or inactive ingredient that needs to be disclosed in the label” because it was not “a purposefully added component of the drug.”  Id. at *27.  (Not long ago, we discussed a decision that postulated that a quasi-manufacturing defect claim could exist because the allegedly harmful substance was not purposefully added to the product.)

Not long before plaintiff bought his acne wash, FDA had advised that benzoyl peroxide products with more than 2 ppm of benzene should not be sold.  However, the monograph had not yet changed, and the acne wash complied with current requirements.  That did not change the analysis.  Nor did the related argument that the manufacturer should have updated its labeling through the same CBE mechanism that confounded the Supreme Court in Levine.  But Kouyate recognized that monograph drugs like the acne wash could not use the CBE regulations.  Id. at *34.

That left the negligence per se claim, which was designed to avoid preemption based on the carveout from preemption under 379r(f) when state requirements identical to FDCA requirements are the basis for liability.  Plaintiff argued that the same labeling issues preempted under his other theories were not preempted because the drug was misbranded under state law; he also argued that the drug was adulterated under state law because having benzene above 2 ppm rendered it harmful, worthless, and illegal to sell.  The problem for plaintiff was that trace benzene from the degradation of benzoyl peroxide does not make the acne wash misbranded or adulterated under the FDCA.  Id. at *38-41.  If, as plaintiff claimed, degradation into benzene is a known, inevitable process, then no acne wash could contain benzoyl peroxide.  Yet, FDA considers these benzoyl peroxide drugs, otherwise compliant with the monograph, to be safe and effective.  Id. at *40.  The mere allegation that the trace amount in plaintiff’s particular product exceeded 2 ppm does not matter because the monograph does not impose any such limit.  The only sources of any such limit are FDA guidances and other non-binding authority.  Id. at *40-43.  Plaintiff’s other arguments, which did not really tie to recognized state law anyway, were unavailing.  We do think that plaintiff’s theories of liability sounded like the stop selling arguments rejected in Bartlett and many cases since.  So, it is hard for us to see how plaintiff can plead non-preempted non-products claims based on the mere presence of benzoyl peroxide and labeling compliant with the current monograph.

The preemption analysis in Leonard was shorter, but no less correct.  The generic OTC drug had an approved ANDA, but it also had monographs relevant to plaintiff’s theory that the defendants had to disclosure that an inactive ingredient, carbomer, was manufactured with benzene.  Like Kouyate, there was certainly no FDA requirement to disclose how the carbomer was made or to refrain from using carbomer made with benzene.  The regulatory requirements were also in some flux when plaintiff purchased her medication in July 2024.  At that time, per FDA guidances, carbomers used as inactive ingredients in drugs were supposed to be in the process of transitioning from a monograph limit of “up to 5,000 ppm” of benzene to a limit of no more than 2 ppm.  Any new requirements, however, were not effective until August 2026.  Unlike in Kouyate, the plaintiff in Leonard did not allege specific testing of benzene in her particular products, just that its choice of carbomer allowed for the possibility of benzene at some level.    She also did not claim that the products failed to comply with actual FDA requirements.  Based on the Dougherty case from the same court, which involved similar claims about a similar product, that meant that any claims based on alleged adulteration or misbranding were preempted.  Id. at *5.  Plaintiff tried to use the decidedly bad decision from the same court in Holley, but the Leonard court recognized that impossibility preemption and express preemption are different.  Id. at *6.  The plaintiff’s claims ran afoul of express preemption by trying to impose requirements different than what the FDCA imposed.  The court also rejected the argument that plaintiff’s claims under California’s version of the federal Sherman Act were automatically parallel claims not subject to express preemption.  But the challenge to “the FDA-approved content and label as adulterated and deceptive” under any claim did attempt “to impose a requirement that is different from or in addition to the federal requirement.”  Id.  As long as plaintiff continues to assert non-product liability claims, it is hard to see how they will not be preempted in Leonard as in Kouyate. 

Given how many times we have written about the preemption of claims based on alleged benzene in FDA-regulated products, including those containing benzoyl peroxide and guaifenesin, we doubt that these will be the last two complaints asserting slightly different versions of the same preempted claims.

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